Aortic occlusion device

• US 10,667,821 B2
• Filed: 11/16/2018
• Issued: 06/02/2020
• Est. Priority Date: 05/13/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Dehdashtian, Mark M., Jimenez, Teodoro S., Satter, Nathan, Schroeder, Fabian Daniel, Mazzei, Raffaele, Kosmoski, Jeff, Zamani, Shahram, Yestrepsky, Adam J.
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US16/193,686
• Publication Number:
  US 20190083102A1
• Time in Patent Office: 564 Days
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 2205/3331 Pressure; Flow

Abstract

Embodiments of aortic occlusion devices are described herein that include radially expandable and collapsible proximal and distal end portions, such as annular self-expanding stents or frames, that are configured to radially expand within an aorta to secure the device within the aorta. The devices can also include a catheter extending axially between the distal end portion and the proximal end portion and a porous covering, or filter, positioned around the catheter and between the proximal end portion and the distal end portion and configured to filter emboli from blood flowing into upper-body arteries. The device can further include a one-way valve positioned at or adjacent to the distal end portion of the device and configured to restrict retrograde blood flow through the device toward the heart.

Claims

1. An aortic occlusion device adapted to radially expand within an aorta to secure the device within the aorta, the device comprising:

a distal expandable portion having an expanded configuration and a delivery configuration, the distal expandable portion comprising a distal portion cylindrical section and a distal portion first conical section, the distal portion cylindrical section comprising a radially expandable lattice of struts defining a plurality of enclosed cells, wherein the distal portion first conical section is secured to a first end of the distal portion cylindrical section, wherein in the expanded configuration the distal portion first conical section extends and tapers away from the distal portion cylindrical section;

a proximal expandable portion having an expanded configuration and a delivery configuration, the proximal expandable portion comprising a proximal portion cylindrical section and a proximal portion first conical section, the proximal portion cylindrical section comprising a radially expandable lattice of struts defining a plurality of enclosed cells, wherein the proximal portion first conical section is secured to a first end of the proximal portion cylindrical section, wherein in the expanded configuration the proximal portion first conical section extends and tapers away from the proximal portion cylindrical section;

a connecting catheter portion extending axially between the distal expandable portion and the proximal expandable portion;

a porous covering positioned around the connecting catheter portion and extending between the proximal expandable portion and the distal expandable portion; and

a valve adapted to restrict retrograde blood flow from passing through the device to the heart.

2. The aortic occlusion device of claim 1, wherein the valve is positioned on or in the distal expandable portion.

3. The aortic occlusion device of claim 1, wherein the first end of the distal portion cylindrical section is a distal end of the distal portion cylindrical section, wherein in the expanded configuration the distal portion first conical section extends and tapers distally away from the distal portion cylindrical section.

4. The aortic occlusion device of claim 3, wherein the valve is positioned on the distal portion first conical section.

5. The aortic occlusion device of claim 1, wherein the first end of the distal portion cylindrical section is a proximal end of the distal portion cylindrical section, wherein in the expanded configuration the distal portion first conical section extends and tapers proximally away from the distal portion cylindrical section.

6. The aortic occlusion device of claim 5, wherein the valve is positioned on the distal portion first conical section.

7. The aortic occlusion device of claim 5, wherein the distal expandable portion further comprises a distal portion second conical section which extends and tapers distally away from a distal end of the distal portion cylindrical section.

8. The aortic occlusion device of claim 7, wherein the valve is positioned on the distal portion second conical section.

9. The aortic occlusion device of claim 1, wherein the first end of the proximal portion cylindrical section is a distal end of the proximal portion cylindrical section, wherein in the expanded configuration the proximal portion first conical section extends and tapers distally away from the proximal portion cylindrical section.

10. The aortic occlusion device of claim 1, wherein the first end of the proximal portion cylindrical section is a proximal end of the proximal portion cylindrical section, wherein in the expanded configuration the proximal portion first conical section extends and tapers proximally away from the proximal portion cylindrical section.

11. The aortic occlusion device of claim 10, wherein the proximal expandable portion further comprises a proximal portion second conical section which extends and tapers distally away from the proximal portion cylindrical section.

12. The aortic occlusion device of claim 1, wherein the valve is positioned on the connecting catheter portion.

13. The aortic occlusion device of claim 1, wherein the device is adapted to be positioned in the aortic arch.

14. The aortic occlusion device of claim 1, wherein the distal expandable portion is adapted to be positioned in the ascending aorta.

15. The aortic occlusion device of claim 1, wherein the proximal expandable portion is adapted to be positioned in the descending aorta.

16. The aortic occlusion device of claim 1, wherein the proximal expandable portion and the distal expandable portion each comprise discretely radially expandable frames.

17. The aortic occlusion device of claim 1, wherein the valve comprises a non-porous liner defining an opening and a sealing member adapted to selectively occlude the opening responsive to blood flow against the sealing member.

18. A system including:

the aortic occlusion device of claim 1;

a cardiopulmonary bypass system configured to provide a flow of oxygenated blood to the aortic occlusion device in a retrograde flow direction; and

a source of cardioplegia fluid in fluid communication with the aortic occlusion device.

19. An aortic occlusion catheter comprising:

a distal expandable portion having an expanded configuration and a delivery configuration, the distal expandable portion comprising a distal portion cylindrical section and a distal portion first conical section, the distal portion cylindrical section comprising a radially expandable lattice of struts defining a plurality of enclosed cells, wherein the distal portion first conical section is secured to a first end of the distal portion cylindrical section, wherein in the expanded configuration the distal portion first conical section extends and tapers away from the distal portion cylindrical section;

a proximal expandable portion having an expanded configuration and a delivery configuration, the proximal expandable portion comprising a proximal portion cylindrical section and a proximal portion first conical section, the proximal portion cylindrical section comprising a radially expandable lattice of struts defining a plurality of enclosed cells, wherein the proximal portion first conical section is secured to a first end of the proximal portion cylindrical section, wherein in the expanded configuration the proximal portion first conical section extends and tapers away from the proximal portion cylindrical section;

a connecting catheter portion extending axially between the distal expandable portion and the proximal expandable portion;

a proximal catheter portion extending proximally from the proximal expandable portion to a proximal end of the aortic occlusion catheter;

a porous covering positioned around the connecting catheter portion and extending between the proximal expandable portion and the distal expandable portion; and

a one-way valve adapted to prevent blood flow from the porous covering through the distal expandable portion in a first direction while permitting blood flow through the distal expandable portion to the porous covering in a second direction.

20. A system including:

the aortic occlusion catheter of claim 19;

a cardiopulmonary bypass system configured to provide a flow of oxygenated blood to the aortic occlusion catheter in a retrograde flow direction; and

a source of cardioplegia fluid in fluid communication with the aortic occlusion catheter.